Preparing for an FDA BIMO Inspection: Dos and Don’ts
LIVE | March 28, 2013 | 08:00 AM PST | 11:00 AM EST | 60 Minutes
About the Seminar
What do you do when you receive a phone call from the FDA announcing an upcoming inspection? Who should you call? Who needs to be notified? What are the first steps towards a satisfactory FDA inspection? What to prepare before the inspection begins? What is to be reviewed by the inspector? What is not to be reviewed by the inspector? How to handle questions pertaining to investigator oversight? How to respond to issues raised by the FDA inspector? What if a Form FDA 483 is issued at the close-out visit? How to respond to the Form FDA 483?
The speaker will be offering suggestions and background information related to this topic as a former FDA investigator and industry expert.
About the Areas to Be Discussed
- Background: FDA inspection authority
- Good clinical practice (GCP)
- What to expect from the FDA inspection
- How to prepare for the FDA BIMO inspection
- How to respond to issues noted during inspection
- Practical tips
About the Intended Attendee(s)
- Regulatory affairs
- Clinical affairs
- Sponsor CQA professionals
- Site personnel (PIs, Coordinators)
- CRO personnel
- 3rd Party auditors
About the Seminar Speaker
FDA Expert Speaker
Mr. Christopher Rush, MBA. Mr. Rush is a former FDA BIMO inspector with global industry auditing experience in pharmaceuticals and medical device clinical trials. Currently, he is President, CEO, and Principal Consultant at FDA Quality and Regulatory Consultants, LLC (www.cdrconsulting.net). He can be reached at email@example.com
via Preparing for an FDA BIMO Inspection: Dos and Don’ts | Global Compliance Seminar.